The Honorable Bart StupakChairSubcommittee on Oversight and InvestigationsU.S. House of Representatives2352 Rayburn House Office BuildingWashington, DC 20515-2201

Dear Congressman Stupak:

The American Society for Microbiology (ASM) would like to submit comments for the consideration of the Energy and Commerce Committee Subcommittee on Oversight and Investigations hearing to examine risks associated with biosafety level 3 and 4 (BSL3 and BSL4) laboratories. The ASM is the largest single life science Society with a membership of over 42,000 scientists and health professionals. Its mission is to advance the microbiological sciences through the pursuit of scientific knowledge and dissemination of the results of fundamental and applied research.

Microbiologists seek to improve public health and the environment through research, diagnostic testing and efforts directed at eradicating infectious diseases that annually end the lives of millions of people around the world. Infectious diseases remain the major cause of death in the world for those under the age of forty-five and are the third leading cause of death in the United States. Some microbiologists work in BSL3 and BSL4 laboratories. These laboratories and facilities are critical to the development of new therapies, diagnostics, prevention and detection methods aimed at reducing the risk of infectious diseases. It is imperativethat the United States develop, support, and enhancea robust network of high containment biosafety laboratories in order to maintain our global pre-eminence in research and diagnostic capacityrelated to current andfuture emerging disease threats. The ASM supports and strives to work for appropriate, adequate and well understood biosafety principles and practices for microbiological laboratories to ensure protection of laboratory personnel, the safety of the surrounding communities, and the efficacy of the research performed.

The ASM wishes to comment on several points related to the topic of the hearing, including:

1) the importance of biocontainment laboratories in light of the rise of new and old infectious diseases with high morbidity and mortality over the past 30 years, as well as the potential for use of microbes for bioterrorism; 2) the importance of biosafety requirements for microbiology laboratories and personnel; and 3) recommendations to improve biosafety training, oversight, resources, reporting and biosecurity.

1.) The Importance of Biocontainment Laboratories, the Rise of Emerging Diseases and the Potential Threat of Bioterrorism

Worldwide, more than fifteen million deaths annually are due to infectious diseases. Infectious diseases respect no borders and make no distinctions among people, especially in a time of unprecedented global travel and commerce. Newly emerging and reemerging infectious diseases are appearing at the same time that microbial resistance to standard therapeutics is on the increase. This lethal combination of events presents enormous challenges to public health. In an age of extensive international air travel and commerce, infectious diseases have become a security issue for every nation on the globe, including the United States. Despite the best efforts of government agencies, the public may be at risk for exposure not only to infectious diseases arising within the United States but also at risk to infectious diseases arising on any continent.

Over the past thirty years, public health agencies have confronted a myriad of infectious diseases, such as HIV/AIDS, Ebola hemorrhagic fever, Lyme disease, toxic shock syndrome, Legionnaires’ disease, hantavirus pulmonary syndrome, West Nile fever, SARS, avian influenza and others. According to the CDC, 75 percent of these emerging and reemerging infectious diseases, including SARS, hantavirus pulmonary syndrome, Nipah virus encephalitis, influenza, and West Nile fever, are zoonotic, which means that they are transmitted from animals to humans. In 2006, public health officials reported the emergence of an old enemy with new power, extensively drug resistant tuberculosis (XDR-TB) that is virtually untreatable with available antimicrobials.

Although terrible to contemplate, we must also confront the possibility of misuse of science for terrorism. As the scientific community fights the onslaught of emerging, reemerging, and drug resistant diseases, it also must prepare to deal with the possibility of an intentional misuse of science for the creation, or spread, of infectious diseases through bioterrorism.

The public looks to skilled and highly trained microbiologists and other health professionals to make every effort to find methods to prevent, diagnose, and treat infectious diseases and to respond rapidly to emerging and reemerging diseases. To meet these challenges, microbiologists must have laboratories in which pathogens may be stored and studied in a manner that is safe to the microbiologists and to the community-at-large.

Congress recognized the seriousness of the threat of bioterrorism in the aftermath of the 2001 anthrax crime and increased appropriations for biodefense research. In early 2002, the National Institute of Allergy and Infectious Diseases (NIAID) convened a panel of experts, the Blue Ribbon Panel on Bioterrorism and its Implications for Biomedical Research. This Panel provided guidance on the future biodefense and emerging diseases research agenda, research resources, facilities and scientific personnel. The NIAID developed research priorities for potential agents of bioterrorism, including the NIAID Strategic Plan for Biodefense Research, the NIAID Biodefense Research Agenda for CDC Category A Agents and the NIAID Biodefense Research Agenda for Category B and C Priority Pathogens. The NIAID has funded a network of 10 nationwide multidisciplinary Regional Centers for Excellence for Biodefense and Emerging Infectious Diseases Research, 2 National Biocontainment Laboratories and 13 Regional Biocontainment Laboratories to provide safe and secure space for biodefense and emerging diseases research. Facilities at BSL 3 and 4 levels of containment have been constructed because the number and capacity of existing biocontainment facilities were determined to be inadequate to meet needs for biodefense and emerging diseases work. These laboratories are also needed to provide surge diagnostic capacity in the event of a bioterrorism attack or a pandemic disease outbreak.

The establishment of new biocontainment laboratories has been done openly and under the scrutiny of local municipalities and a federal regulatory and oversight system. They have been constructed in accordance with environmental impact assessments and other applicable standards for biosafety. The new BSL3 and BSL4 laboratories constructed with funds provided in part by the National Institutes of Health (NIH) have been subject to rigorous oversight by NIH/NIAID program staff throughout all phases of design and construction.

2.) The Importance of Biosafety Requirements for Microbiology Laboratories and Personnel

Laboratories with capacity at BSL3 and BSL4 are designed to maximize the safety of laboratory staff and minimize the potential that a pathogen could escape. They must follow biosafety procedures to protect personnel working in the laboratory and the outside community. These laboratories are subject to federal laws, regulations and policies which seek to ensure a safe and secure environment in which to conduct research on dangerous pathogens and toxins.

The Biosafety in Microbiological and Biomedical Laboratories, BMBL, 5th Edition, published by the CDC and NIH, describes microbiological practices, laboratory facilities and safety equipment for infectious agents. Through the BMBL, CDC and NIH have set standard procedures for the safe handling of infectious agents in the laboratory and best practices to ensure biosafety. The shipment of infectious agents is regulated by the DOT, Department of Commerce, CDC and USDA. Bloodborne pathogens are regulated by OSHA. The NIH Guidelines for Research Involving Recombinant DNA Molecules establish safety guidelines for research with recombinant DNA and infectious agents. They require institutions receiving NIH funding to have Biosafety Officers and Institutional Biosafety Committees (IBCs). The NIH Office of Biotechnology Activities provides resources and training on the role and responsibilities of IBCs, which examine research protocols, expertise, potential hazards and containment plans. Many institutions assign IBCs broader responsibility for overseeing research with nonrecombinant infectious agents. The NIH Recombinant DNA Advisory Committee provides expert advice on issues related to the NIH Guidelines.

Institutions are required to comply with the CDC and US Department of Agriculture Select Agent regulations if they possess, use, or transfer certain expressly identified select agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety. These regulations mandate an FBI security risk assessment for individuals authorized to have access to select agents, incident response plans, and a security and safety plan to safeguard the select agents (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). The NIH Recombinant DNA Guidelines and the Select Agent Regulations specify reporting requirements for any significant problems, violations, or any research related accidents and illnesses.

Although there are procedures in place for providing biosafety if properly followed, there is always a need to enhance biosafety. In this regard, there is need to ensure adequate training and strict compliance to provide the levels of protection engendered in those procedures. Laboratory workers who handle infectious pathogens are at potential risk of acquiring an infection. Therefore, adequate training in microbiological practices and biosafety is essential to working safely with hazardous biological agents, and protecting the public health. Exposure and risk may be prevented or minimized by rigorous implementation of appropriate laboratory practices and containment, safety equipment, improvement and maintenance of facilities and formal, validated training of technical, support and administrative personnel. Risk assessment is very important because it enables the selection of the appropriate microbiological practices, safety equipment and facility safeguards for research and testing.

Training: It is essential that personnel in laboratories where work with biohazardous agents is conducted are trained to a level of competence that provides for their own safety and that of the community. Hence there should be mandatory, periodic training for all personnel working in BSL3 and BSL4 laboratories. Learning competencies should be established for biosafety training and formal training programs should be required and documented. The training that laboratory personnel receive should be validated to ensure the adequacy of biosafety knowledge. Not only should laboratory personnel be properly trained, but also those who are responsible for facility operations, equipment and management should receive training.

The NIH Regional Centers of Excellence serve an important role for training and exchange of information about biosafety practices. Their role should be encouraged and enhanced. Extramural civilian biodefense research is at an early stage and it is important to learn from experience and share information.

Oversight: Oversight of biosafety at multiple levels is essential. Harmonized integrated systems of oversight of all pathogens are needed. Institutional Biosafety Committees, Biosafety Officers and Laboratory Directors, which evaluate risk and safety issues at the local level, as well as the institutionally designated Select Agent Responsible Officials, should ensure institutional adherence to the BMBL, the NIH Guidelines, and other applicable regulations for laboratory safety and security. To assist them, the NIH and CDC should make educational and training programs available and mandatory for biosafety personnel.

The CDC and NIH should ensure that good communication channels are in place for biosafety personnel to assist them in making informed decisions about risk management. The NIH and the CDC should consider further guidance and outreach activities for biosafety personnel to assist them in making informed decisions about regulatory interpretation and containment for research on highly infectious agents and new scientific techniques, where guidance and uniformity of risk information may not be well established. Biosafety personnel should work closely with researchers in containment settings to review and improve safety procedures that protect public health.

The NIH should ensure that biosafety personnel have a clear understanding of the circumstances for consulting with the NIH Office of Biotechnology Activities on research containment and regulatory issues. The BMBL and the NIH Guidelines are essential reference documents for biosafety practice and oversight and should be required by institutions conducting research. The CDC and NIH should work with research institutions, the scientific and biosafety communities to ensure that current biosafety guidelines, regulations for biosafety and biosecurity are well understood, appropriate and implemented to ensure safe laboratory procedures. Understanding and adhering to biosafety principles and practices, risk assessment, appropriate containment and facility safeguards will contribute to safe laboratories, research and testing.

Resources:Biocontainment laboratories are expensive and a large investment, not only in the cost of construction, but in the cost of operations, maintenance, training, oversight and community relations. The design and building of biocontainment facilities requires careful guidance from funding agencies, the development of useful standards for biosafety experts and managers to ensure effective biosafety, oversight and inspection. Facilities must ensure that maintenance and renovations do not result in breeches of containment.

The needs for additional support for biosafety oversight and maintenance of biocontainment laboratories should be evaluated to ensure there is adequate institutional and agency support. It is important that the investments made to date by the government in these laboratories be sustained to ensure their continued safe operation. As needed, the Congress should enhance funding to ensure that biosafety needs, and especially training needs, are met.

Reporting: Laboratory acquired infections have been documented in the United States. However, better surveillance and reporting of laboratory acquired illness and response should be established, even for those incidents not covered by the Select Agent regulations. Notifiable infectious diseases must now be reported to local and/or state public health agencies to enable assessment of risk and response and to alert physicians and the public to take appropriate steps, if necessary. There should be a reporting requirement for illnesses suspected of being laboratory acquired. CDC and local/state public health authorities should work with institutions, investigators and biosafety personnel to analyze occurrences of laboratory acquired illnesses and to provide reports and information in a way that will help reduce the risk and reoccurrence of any incidents. Improved reporting of laboratory acquired illness, investigation and response would provide valuable lessons for maintaining safe conditions in research and clinical laboratories.

Biosecurity: The most recent update of the Select Agent regulations was finalized in March of 2005. In just over two years, the select agent regulatory program has focused on the establishment of facilities and personnel for the safe and secure study of select agents. As the program gains experience, effective oversight approaches that ensure public health and safety and the productivity of research efforts should be examined. It is important that the CDC and APHIS Select Agent programs and the NIH provide outreach and educational programs to assist institutions and those responsible for biosafety, biosecurity and for the safe handling of any laboratory incidents.

We recommend that the NIH and CDC work with research institutions and the extramural community to discuss and find ways to improve, promote and enforce biosafety standards and training for working with infectious agents. The ASM appreciates the opportunity to provide comments and recommendations for the consideration of Congress and stands ready to be of assistance in any way.